BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation

A Phase IIb open label study evaluates the safety and efficacy of repeat doses of BPC2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (aGvHD) in subjects following Haploidentical Stem Cell Transplantation (Haplo-SCT).

Inclusion Criteria: 1. Male or female ages ≥18 and ≤ 65 years. 2. Before the start of the trial, the subject or his/her guardian is sufficient to understand and voluntarily sign the written informed consent form (ICF). 3. Subjects have a hematologic malignancy as defined below and are considered candidates for haplo-SCT: 1. Acute leukemia with morphologic complete remission (acute myelogenous leukemia \[AML\] or acute lymphoblastic leukemia \[ALL\]); 2. Myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myeloproliferative neoplasm (MPN) with \< 10% blasts in the bone marrow. 4. Organ function tolerated for transplantation: 1. Cardiac function: Left ventricular ejection fraction at rest ≥ 45%; 2. Liver function: Total bilirubin \< 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × ULN. Subjects who have been diagnosed with Gilbert's syndrome or malignant disease involvement are allowed to have a total bilirubin value \> 1.5 × ULN; 3. Serum creatine \< 2 mg/dL or estimated creatinine clearance \> 50 mL/min calculated using the Cockcroft-Gault equation； 4. Pulmonary function tests (PFTs): diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) and/or forced expiratory volume in 1 second (FEV1) ≥ 50%. 5. Subject is suitable for myeloablative haplotype related donor transplant. 6. Subject is suitable for receiving first alloHSCT. 7. The transplant donor must meet the following criteria: 1. Donor ages \> 30 years; If the donor ages is equal to or less than 30 years, the donor should be female for male subject; 2. High-resolution typing of human leukocyte antigen (HLA)-A, -B, -C, DR, and DQ are matched at least 5/10; 3. Meet the criteria for peripheral blood stem cell (PBSC) donation; 4. Donor's specific antibodies are negative, \